STRATTERA 100MG HARD CAPSULES

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Strattera 10, 18, 25,
40, 60, 80 and 100 mg
hard capsules
®

Atomoxetine

Important things you need to know about your medicine
This medicine is used to treat ADHD
•
The full name for ADHD is ‘Attention Deficit
Hyperactivity Disorder’.
•
The medicine helps with your brain activity. It can help
improve your attention, help you concentrate, and make
you less impulsive.
•
You need to have other help for ADHD as well as this
medicine.
Read Section 1 for more information.
Before you take this medicine, talk to your doctor if
you:
• have mental health problems
• have a problem with your heart or blood circulation
•
have serious problems with the blood vessels in your
brain such as a stroke
Read Section 2 for more information.
While taking this medicine:
•
See your doctor regularly. This is because your doctor
will want to check how the medicine is working.
• not stop taking the medicine without first talking to
Do
your doctor.
•
Your doctor may stop your medicine to see if it is still
needed, if you take it for more than a year.
•
The most common side effects in children and young
people are:

-
problems with your heart (including heart defects) or
an increased heartbeat. Strattera can increase your
heart rate (pulse). Sudden death has been reported in
patients with heart defects
-
high blood pressure. Strattera can increase blood
pressure
- blood pressure. Strattera can cause dizziness or
low
fainting in people with low blood pressure
-
problems with sudden changes in your blood pressure
or your heart rate
-
cardiovascular disease or past medical history of stroke
-
liver problems. You may need a lower dose
-
psychotic symptoms including hallucinations (hearing
voices or seeing things which are not there), believing
things that are not true or being suspicious
-
mania (feeling elated or over-excited, which causes
unusual behaviour) and agitation
- aggressive feelings
-
unfriendly and angry (hostility) feelings
- history of epilepsy or have had seizures for any other
a
reason. Strattera might lead to an increase in seizure
frequency
-
different moods than usual (mood swings) or feel very
unhappy
-
hard-to-control, repeated twitching of any parts of the
body or you repeat sounds and words
Tell your doctor or pharmacist if any of the above applies
to you before starting treatment. This is because Strattera
can make these problems worse. Your doctor will want to
monitor how the medicine affects you.
Checks that your doctor will make before you start to
take Strattera
These checks are to decide if Strattera is the correct
medicine for you.
Your doctor will measure your
-
blood pressure and your heart rate (pulse) before and
during the time you take Strattera
-
your height and weight if you are a child or teenager
during the time you take Strattera

Read Sections 3 and 4 for more information.

Your doctor will talk to you about:
- any other medicines you are taking
-
whether there is any family history of sudden
unexplained death
- other medical problems (such as heart problems)
any
you or your family may have

Talk to your doctor straight away if any of the
following happen:
• your mood and how you feel changes
•
you feel any problems with your heart e.g a fast or
unusual heartbeat rhythm

It is important that you provide as much information as
you can. This will help your doctor decide if Strattera is
the correct medicine for you. Your doctor may decide that
other medical tests are needed before you start taking this
medicine.

Read Section 2 and 4 for more information.
The rest of this leaflet includes more detail and other
important information on the safe and effective use of
this medicine.
• Keep this leaflet. You may need to read it again.
• you have any further questions, ask your doctor or
If
pharmacist.
•
This medicine has been prescribed for you only. Do not
pass it on to others.
• may harm them, even if their signs of illness are the
It
same as yours.
• you get any side effects, talk to your doctor or
If
pharmacist. This includes any possible side effects not
listed in this leaflet.
The leaflet has been written in sections:
Sections 1 to 6 are for parents and carers (sometimes
called ‘your guardians’).
The last section is a special section for a child or young
person to read.
However, all sections are written as though the child or
young person taking the medicine is reading them.
What is in this leaflet:
1. What Strattera is and what it is used for
2. What you need to know before you take Strattera
3. How to take Strattera
4. Possible side effects
5. How to store Strattera
6. Contents of the pack and other information
1. WHAT STRATTERA IS AND WHAT IT IS USED FOR
What it is used for
Strattera contains atomoxetine and is used to treat
attention-deficit and hyperactivity disorder (ADHD). It is
used
- in children over six years of age
- in young people
- in adults
It is used only as a part of the total treatment of the disease
which also requires treatments which do not involve
medicines, such as counselling and behavioural therapy.
It is not for use as a treatment for ADHD in children under
6 years of age as it is not known if the drug works or is safe
in these people.
In adults, Strattera is used to treat ADHD when the
symptoms are very troublesome and affect your work
or social life and when you have had symptoms of the
disease as a child.
How it works
Strattera increases the amount of noradrenaline in the
brain. This is a chemical that is produced naturally, and
increases attention and decreases impulsiveness and
hyperactivity in patients with ADHD. This medicine has
been prescribed to help control the symptoms of ADHD.
This medicine is not a stimulant and is therefore not
addictive.
It may take a few weeks after you start the medicine for
your symptoms to fully improve.
About ADHD
Children and young people with ADHD find it:
• hard to sit still and
• hard to concentrate.
It is not their fault that they cannot do these things. Many
children and young people struggle to do these things.
However, with ADHD this can cause problems with
everyday life. Children and young people with ADHD may
have difficulty learning and doing homework. They find it
hard to behave well at home, at school or in other places.
ADHD does not affect the intelligence of a child or young
person.
Adults with ADHD find it difficult to do all the things that
children find difficult; however this may mean they have
problems with:
• work
• relationships
• low self esteem
• education
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
STRATTERA
Do NOT take Strattera if you:
- allergic (hypersensitive) to atomoxetine or any of
are
the other ingredients of Strattera (see section 6)
-
took a medicine known as a monoamine oxidase
inhibitor (MAOI), for example phenelzine, in the last
two weeks. An MAOI is sometimes used for depression
and other mental-health problems; taking Strattera with
an MAOI could cause serious side effects or be lifethreatening. You also need to wait at least 14 days after
you stop taking Strattera before you take an MAOI
-
have an eye disease called narrow-angle glaucoma
(increased pressure in your eye)
-
have serious problems with your heart which may
be affected by an increase in heart rate and/or blood
pressure, as this may be an effect of Strattera
-
have serious problems with the blood vessels in your
brain - such as a stroke, swelling and weakening of
part of a blood vessel (aneurysm) or narrow or blocked
blood vessels
- v e a t u m o u r o f y o u r a d r e n a l g l a n d
ha
(phaeochromocytoma)
Do not take Strattera if any of the above applies to you. If
you are not sure, talk to your doctor or pharmacist before
you take Strattera. This is because Strattera can make
these problems worse.
Warnings and Precautions
Talk to your doctor before taking Strattera if you have:
-
thoughts about killing yourself or trying to kill yourself

Other medicines and Strattera
Tell your doctor or pharmacist if you are taking, have
recently taken or plan to take any other medicines. This
includes non-prescription medicines. Your doctor will
decide if you can take Strattera with your other medicines
and in some cases your doctor may need to adjust your
dose or increase your dose much more slowly.
Do not take Strattera with medicines called MAOI’s
(monoamine oxidase inhibitors) used for depression. See
section 2 “Do not take Strattera”.
If you are taking other medicines, Strattera may affect how
well they work or may cause side effects. If you are taking
any of the following medicines, check with your doctor or
pharmacist before taking Strattera:
-
medicines that increase blood pressure or are used to
control blood pressure
-
medicines such as antidepressants, for example
imipramine, venlafaxine, mirtazapine, fluoxetine and
paroxetine
-
some cough and cold remedies which contain
medicines that can affect blood pressure
is important to check with your pharmacist when you
It
buy any of these products
-
some medicines used to treat mental health conditions
-
medicines that are known to increase the risk of
seizures
-
some medicines that cause Strattera to stay in the
body for longer than normal (such as quinidine and
terbinafine)
-
salbutamol (a medicine to treat asthma) when taken by
mouth or injected may make you feel as if your heart is
racing, but this will not make your asthma worse
The medicines below may lead to an increased risk of an
abnormal rhythm of the heart when taken with Strattera:
-
medicines used to control the rhythm of the heart,
-
medicines which change the concentration of salts in
the blood,
- medicines for malaria prevention and treatment,
-
some antibiotic medicines (such as erythromycin and
moxifloxacin).
If you are not sure about whether any medicines you are
taking are included in the list above, ask your doctor or
pharmacist before taking Strattera.
Pregnancy, breast-feeding and fertility
It is not known if Strattera can affect an unborn baby or
pass into breast milk.
-
Strattera should not be used during pregnancy, unless
your doctor has advised you to do so.
-
You should either avoid taking Strattera if you are
breastfeeding or discontinue breastfeeding.
If you are:
- pregnant or breast feeding,
-
thinking that you may be pregnant or are planning to
have a baby,
- planning to breastfeed your baby,
ask your doctor or pharmacist for advice before taking
Strattera.
Driving and using machines
You may feel tired, sleepy or dizzy after taking Strattera.
You should be careful if you are driving a car or operating
heavy machinery until you know how Strattera affects you.
If you feel tired, sleepy or dizzy you should not drive or
operate hazardous machinery.
Important information about the content of the capsules
Do not open Strattera capsules because the contents
of the capsule can irritate the eye. If the contents of the
capsules come into contact with the eye, the affected eye
should be flushed immediately with water, and medical
advice obtained. Hands and any other part of the body
that may have come into contact with the capsule contents
should also be washed as soon as possible.
3. HOW TO TAKE STRATTERA
-
Always take Strattera as your doctor has told you. This
is usually one or two times a day (morning and late
afternoon or early evening)
- you are taking Strattera once a day and experience
If
sleepiness or feel sick, your doctor may change your
treatment schedule to twice a day
-
The capsules should be swallowed whole, either with or
without food
-
The capsules should not be opened and the contents
inside the capsules should not be removed and taken in
any other way
-
Taking the medicine at the same time each day may
help you remember to take it
How much to take
If you are a child or teenager (6 years or older):
Your doctor will tell you how much Strattera you should
take and will calculate this according to your weight.
He/she will normally start you on a lower dose before
increasing the amount of Strattera you need to take
according to your body weight.
-
Body weight up to 70kg: a starting total daily dose of
0.5mg per kg of body weight for a minimum of 7 days.
Your doctor may then decide to increase this to the
usual maintenance dose of about 1.2mg per kg of body
weight daily.
-
Body weight over 70kg: a starting total daily dose of
40 mg for a minimum of 7 days. Your doctor may then
decide to increase this to the usual maintenance dose
of 80mg daily. The maximum daily dose your doctor will
prescribe is 100 mg.
Adults
-
Strattera should be started at a total daily dose of
40 mg for a minimum of 7 days. Your doctor may then
decide to increase this to the usual maintenance dose
of 80mg-100mg daily. The maximum daily dose your
doctor will prescribe is 100 mg.

Information for children and young people
This information is to help you learn the main things about
your medicine called Strattera.
If you don’t enjoy reading, someone like your mum, dad or
carer (sometimes called ‘your guardian’) can read it to you
and answer any questions.
It may help if you read small bits at a time.
Why have I been given this medicine?
This medicine can help children and young people with
‘ADHD’.
•
ADHD can make you:
- run about too much
- not be able to pay attention
- quickly without thinking about what will happen
act
next (impulsive)
• affects learning, making friends and how you think
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about yourself. It is not your fault.
While you are taking this medicine
• well as taking this medicine you will also get help
As
with ways to cope with your ADHD such as talking to
ADHD specialists.
•
This medicine should help you. But it does not cure
ADHD.
•
You will need to go to your doctor several times a
year for check-ups. This is to make sure the medicine
is working and that you are growing and developing
all right.

Item Code

•
Girls must tell their doctor straight away if they think
they may be pregnant. We do not know how this
medicine affects unborn babies. If you are having sex,
please talk to your doctor about contraception.
Some people cannot have this medicine
You cannot have this medicine if you:
•
took a medicine known as a monoamine oxidase
inhibitor (MAOI), for example phenelzine, in the last two
weeks
•
have an eye disease called narrow-angle glaucoma
(increased pressure in your eye)
•
have a serious problem with your heart
•
have serious problems with the blood vessels in your
brain
•
have a tumour of your adrenal gland
Some people need to talk to their doctor before they
start taking this medicine
You need to talk to your doctor if you:
• are pregnant or breastfeeding
• taking other medicines – your doctor needs to know
are
about all the medicines you are taking
• have thoughts about hurting yourself or others
•
have problems with you heart beating too fast or
skipping beats while you are not exercising
• hear voices or see things that others do not
• have problems with getting angry easily

If you have problems with your liver your doctor may
prescribe a lower dose.
If you take more Strattera than you should contact
your doctor or the nearest hospital casualty department
immediately and tell them how many capsules you
have taken. The most commonly reported symptoms
accompanying overdoses were gastrointestinal symptoms,
sleepiness, dizziness, tremor, and abnormal behaviour.
If you forget to take Strattera
If you miss a dose, you should take it as soon as possible,
but you should not take more than your total daily dose in
any 24-hour period. Do not take a double dose to make up
for forgotten doses.
If you stop taking Strattera
If you stop taking Strattera there are usually no side effects
but your ADHD symptoms may return. You should talk to
your doctor first before you stop treatment.
Things your doctor will do when you are on treatment
Your doctor will do some tests
-
before you start - to make sure that Strattera is safe
and will be of benefit.
-
after you start - they will be done at least every 6
months, but possibly more often.
They will also be done when the dose is changed. These
tests will include:
-
measuring height and weight in children and young
people
-
measuring blood pressure and heart rate
-
checking whether you have any problems or if side
effects have got worse while taking Strattera
Long-term treatment
Strattera does not need to be taken for ever. If you take
Strattera for more than a year, your doctor will review your
treatment, to see if the medicine is still needed.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Strattera can cause side effects,
although not everybody gets them. Although some people
get side effects most people find that Strattera helps them.
Your doctor will talk to you about theses sides effects.
Some side effects could be serious. If you have any of
the side effects below, see a doctor straight away.
Uncommon (affects less than 1 in 100 people)
-
feeling or having a very fast heartbeat, abnormal
rhythms of the heart
- thinking about or feeling like killing yourself
- feeling aggressive
- feeling unfriendly and angry (hostility)
- mood swings or mood changes
- serious allergic reaction with symptoms of
- swelling of the face and throat
- difficulty breathing
- hives (small raised, itchy patches of skin)
- seizures
-
psychotic symptoms including hallucinations (hearing
voices or seeing things which are not there), believing
things that are not true or being suspicious
Children and young adults aged under 18 have an
increased risk (affects less than 1 in 100 people) of side
effects such as:
- thinking about or feeling like killing yourself
- mood swings or mood changes
Adults have a reduced risk (affects less than 1 in 1000
people) of side effects such as:
- seizures
-
psychotic symptoms including hallucinations (hearing
voices or seeing things which are not there), believing
things that are not true or being suspicious
Rarely (affects less than 1 in 1000 people)
- liver injury
You should stop taking Strattera and call your doctor
immediately if you have any of the following:
- dark urine
- yellow skin or yellow eyes
-
tummy pain which is sore when you press it
(tenderness) on the right side just below your ribs
- a feeling of sickness (nausea) that is unexplained
- tiredness
- itching
- feeling that you are coming down with flu
Other side effects reported include the following. If they
get serious, tell your doctor or pharmacist.

Very Common side effects
(affects more than 1 in 10 people)
CHILDREN and YOUNG
PEOPLE over 6 years

•
Swallow your medicine with water either with or without
food.
•
The capsules should not be opened. If the capsule
breaks and the contents inside the capsules come into
contact with your skin or eyes, get help from an adult.
•
Your doctor will tell you how many times a day you
should take your medicine.
•
Take your medicine at the same time each day may
help you remember to take it.
• not stop taking the medicine without talking to your
Do
doctor first.
Possible side effects

Side effects are the unwanted things that can happen
when you take a medicine. If any of the following happen,
tell an adult you trust straight away. They can then talk to
your doctor. The main things that could affect you are:
• Your heart beating faster than usual
•
Being very depressed and unhappy or wanting to hurt
yourself
• Feeling aggressive
•
Being very unhappy or having different moods than
usual (mood swings)
•
Showing signs of an allergic reaction such as rash,
itching or hives on the skin, swelling of the face, lips,
tongue or other parts of the body, shortness of breath,
wheezing or trouble breathing
•
Having fits (seizures)

Effects on growth
Some children experience reduced growth (weight and
height) when they start taking Strattera. However, with
long-term treatment, children recover to the weight and
height for their age range.
Your doctor will watch your child’s height and weight over
time. If your child is not growing or gaining weight as
expected, your doctor may change your child’s dose or
decide to stop Strattera temporarily.
Reporting of side effects
Please tell your doctor or pharmacist if:
•
you get any of these side effects and they become
troublesome or get worse
• notice any side effects not mentioned in this leaflet.
you
You can also report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE STRATTERA
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton and
blister after ‘Exp’. The expiry date refers to the last day of
that month.
This medicinal product does not require any special
storage conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. ONTENTS OF THE PACK AND OTHER
C
INFORMATION
What Strattera 10, 18, 25, 40, 60, 80 and 100 mg hard
capsules contain
-
The active substance is atomoxetine hydrochloride.
Each hard capsule contains atomoxetine hydrochloride
equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg,
80 mg or 100 mg of atomoxetine.
-
The other ingredients are pregelatinised starch and
dimeticone.
-
The capsule shells contain sodium laurilsulfate and
gelatin. The capsule shell colourants are:

•
Seeing, feeling, or hearing things that other people
do not
•
Liver injury: tummy pain which is sore when you press it
(tenderness) on the right side just below your ribs
As the medicine can make you feel sleepy, it is important
not to do outdoor sports like riding a horse or bike,
swimming or climbing trees. You could hurt yourself and
others.
If you feel unwell in any way while you are taking your
medicine please tell an adult you trust straight away.
Other things to remember

•
Make sure you keep your medicine in a safe place, so
that no one else takes it, especially younger brothers or
sisters.
•
The medicine is only for you - do not let anyone else
have it. It may help you, but it could hurt someone else.
• you forget to take your medicine don’t take two tablets
If
the next time. Just take one tablet at the next normal
time.
• you do take too much medicine, tell your mum, dad or
If
carer right away.
• is important not to take too much medicine or you will
It
get ill.
•
Don’t stop taking your medicine until your doctor says
it’s OK.
Who should I ask if there is anything I don’t understand?

Your mum, dad, carer, your doctor, nurse or pharmacist
will be able to help you.
PA000SPAA03

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